Post-op hypoglycaemia - Single mini-doses of dasiglucagon effectively reduced time spent in hypoglycaemia after meals in individuals who have undergone bariatric surgery

Zealand Pharma, a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, has announced positive topline results from a Phase 2 clinical trial using mini-doses of dasiglucagon in individuals who have undergone gastric bypass bariatric surgery.

The Phase 2 clinical trial, conducted by the Center for Clinical Metabolic Research Herlev-Gentofte Hospital, University of Copenhagen, was designed as a double-blinded, randomised, three-period, crossover study. It comprised three separate treatment days, in which subjects, who had previously undergone a gastric bypass bariatric procedure and had a history of post-prandial hypoglycaemia, underwent a mixed meal tolerance test, a standardised meal of specified macronutrient content. Subjects were randomly assigned to be treated with two different subcutaneous administered doses of dasiglucagon (80μg and 200μg) and placebo (saline injection) after the meal.

Dasiglucagon is a glucagon analog with a unique stability profile in a ready-to-use aqueous solution. It is also in development for three additional indications: treatment of severe hypoglycaemia, treatment of type 1 diabetes with a next-generation artificial pancreas and treatment for children born with a genetic mutation that causes congenital hyperinsulinism.

“We are very happy to see that dasiglucagon can potentially help patients suffering from recurrent hypoglycaemia after bariatric surgery,” said Professor Filip K Knop, Director of Center for Clinical Metabolic Research at Herlev-Gentofte Hospital. “This post-operative condition is increasingly recognised as one disabling many patients from their normal daily life and activities, and there is a great unmet medical need for viable treatment options that can prevent and treat these hypoglycaemic episodes.”

The results demonstrate that both dasiglucagon doses significantly reduced meal-induced hypoglycaemia compared to placebo in individuals who have undergone gastric bypass bariatric surgery. Time spent in post-meal hypoglycaemia (plasma glucose <3.9mmol/L) was on average 62.0 minutes with placebo and 27.5 and 14.0 minutes with 80μg and 200μg dasiglucagon, respectively (P<0.05 versus placebo for both). Dasiglucagon was well tolerated, with one subject reporting nausea and two subjects reporting nausea and vomiting in the high dose dasiglucagon group. No serious adverse events occurred.

“We are very encouraged with the results of this Phase 2 study demonstrating the potential of dasiglucagon in treatment of individuals with recurrent episodes of meal-induced hypoglycemia following bariatric surgery,” commented Adam Steensberg, Executive Vice President of Research and Development, and Chief Medical Officer at Zealand Pharma. “We look forward to further investigating dasiglucagon’s efficacy and safety as a potential treatment for individuals living with this challenging condition.”